Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 52060 [2024-13638]

Download as PDF 52060 Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in section 512(n)(1) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360b(n)(1)) have been approved under OMB control number 0910–0669. guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: June 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–13690 Filed 6–20–24; 8:45 am] BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2023–N–4066; FDA– 2023–N–0918; FDA–2023–N–4259; FDA– 2023–N–4849; and FDA–2021–N–0471] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/animal-veterinary/ been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have SUMMARY: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection FDA Recall Regulations .......................................................................................................................................... Food Labeling Regulations ...................................................................................................................................... Export Certificates for FDA Regulated Products ..................................................................................................... Food Allergen Labeling and Reporting .................................................................................................................... Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption—Agricultural Water ............................................................................................................................................................ Dated: June 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–13638 Filed 6–20–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ddrumheller on DSK120RN23PROD with NOTICES1 [Docket No. FDA–2017–D–0154] Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft SUMMARY: VerDate Sep<11>2014 17:46 Jun 20, 2024 Jkt 262001 guidance for industry entitled ‘‘Considerations in Demonstrating Interchangeability With a Reference Product: Update.’’ This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). After considering any comments received in the docket for this draft guidance, we intend to revise the final guidance for industry entitled ‘‘Considerations in Demonstrating Interchangeability With a Reference Product’’ issued on May 14, 2019, to amend sections in that document regarding the subject addressed in this draft guidance. Submit either electronic or written comments on the draft guidance DATES: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Date approval expires 0910–0249 0910–0381 0910–0498 0910–0792 6/30/2027 5/31/2027 6/30/2027 6/30/2027 0910–0816 6/30/2027 by August 20, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such E:\FR\FM\21JNN1.SGM 21JNN1

Agencies

[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Page 52060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2023-N-4066; FDA-2023-N-0918; FDA-2023-N-4259; FDA-
2023-N-4849; and FDA-2021-N-0471]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
FDA Recall Regulations..................       0910-0249       6/30/2027
Food Labeling Regulations...............       0910-0381       5/31/2027
Export Certificates for FDA Regulated          0910-0498       6/30/2027
 Products...............................
Food Allergen Labeling and Reporting....       0910-0792       6/30/2027
Standards for the Growing, Harvesting,         0910-0816       6/30/2027
 Packing, and Holding of Produce for
 Human Consumption--Agricultural Water..
------------------------------------------------------------------------


    Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13638 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P


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